Non-custom dental treatment trays and mouth guards having improved anatomical features

ABSTRACT

A non-custom, dental tray device includes a moisture-resistant barrier layer having a labial-buccal wall, a lingual wall, and a bottom wall. The dental tray device includes at least one of the following structural features to enhance the fit of the device; (1) the bottom wall includes an abrupt reduction of width at a location corresponding to where the first bicuspid meets the canine; (2) a bottom wall in the posterior region having a width that is equal to or less than the width of the bottom wall in the anterior region, with no lingual wall in the posterior region; or (3) a transition portion between the bottom wall and either the labial-buccal wall or the lingual wall has a larger radius of curvature as compared to a radius of curvature at a transition portion between the bottom wall the other of the labial-buccal wall and the lingual wall.

RELATED APPLICATIONS

The present application is a continuation-in-part of co-pending U.S.application Ser. No. 11/467,333, filed Aug. 25, 2006, the disclosure ofwhich is incorporated herein in its entirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention is in the field of dental tray shaped treatmentdevices used to provide a desired dental treatment to a person's teeth.The treatment device can be used for dental treatments such asbleaching, administration of fluoride, or application of othermedicines.

2. The Relevant Technology

Virtually all people desire white or whiter teeth. A common bleachingmethod involves the use of a dental tray that is custom-fitted to aperson's teeth and that is therefore comfortable to wear. One type ofcustomized tray is made from a stone cast of a person's teeth. Anotheris customized directly using a person's teeth as a template (e.g.,“boil-and-bite” trays). Non-customized trays that approximate the shapesand sizes of a variety of users' dental arches have also been used. Adental bleaching composition is placed into the tray and the tray placedover the person's teeth for a desired period of time.

Another tooth bleaching method involves placing a flexible bleachingstrip over a user's tooth surfaces. Conventional bleaching stripscomprise a flexible plastic strip coated with a dental bleaching gel ofmoderate viscosity and relatively low stickiness on the side of thestrip facing the user's teeth. To install the bleaching strip, a portionof the bleaching strip is placed over the front surfaces of the user'steeth, and the remainder is folded around the occlusal edges of theteeth and against a portion of the lingual surfaces.

Because of the generally poor adhesion of bleaching strips to the user'steeth, coupled with their generally flimsy nature, it is often difficultfor the user to maintain the bleaching strip in its proper position forthe recommended time. Conventional bleaching strips are prone to slipoff the teeth as a result of even minimal movement of the user's mouth,jaw or tongue. It is recommended that the user not eat, drink, smoke orsleep while wearing the bleaching strip. In some cases, the bleachingstrip can become so dislodged or mangled that it must be removed by theuser and replaced with a fresh bleaching strip to complete therecommended bleaching time.

Ultimately, the main impediment to successful bleaching is the failureof users to complete the prescribed bleaching regimen. If the bleachingapparatus is difficult to install over a person's teeth, requiresnumerous repetitions to achieve observable results, or is uncomfortableto wear, the user may simply give up and prematurely abort theprescribed bleaching regimen. Thus, even if dental bleaching is possibleusing a particular bleaching apparatus or method, it is less likely tooccur if the inadequacies of the bleaching apparatus or method cause auser to become discouraged before desired results are attained.

In view of the foregoing, there is an ongoing need for improvedbleaching apparatus and methods that are simple and easy to use and thatreliably remain in position over the user's teeth so as to reducediffusion of bleaching composition into a user's oral cavity. Suchimprovements would be expected to improve or encourage compliance by theuser.

BRIEF SUMMARY OF THE PREFERRED EMBODIMENTS

The present invention is directed to non-custom dental tray devicessuitable for placement over at least a portion of a person's dentalarch. The dental tray device may comprise a dental treatment tray ormouth guard. The dental tray devices comprise a moisture-resistantbarrier layer formed of a polymeric material having generally ahorseshoe shape tray-like configuration that substantially correspondsto the curvature of a person's dental arch. The dental tray deviceincludes a labial-buccal wall, a lingual wall, and a bottom wallinterposed between the labial-buccal wall and the lingual wall. Thedental tray device is non-customized (i.e., is substantially devoid ofstructures corresponding to the size and shape of a person's uniquedentition so that the tray is designed to fit over a plurality ofdifferently-sized and/or shaped teeth corresponding to differentpeople).

The barrier layer includes one or more structural features thatfacilitate the ability of the barrier layer to better conform to aplurality of differently sized and/or shaped teeth when worn. Thestructural features included in the barrier layer include at least oneof: (1) an abrupt reduction of a width of the bottom wall at a locationcorresponding to a transition between posterior teeth and anterior teethto account for the significant difference between the occlusal surfacewidth of the posterior teeth as compared to the anterior teeth; (2) awidth of the bottom wall in the posterior region of the tray being equalto or less than a width of the bottom wall in the anterior region of thetray, and the lingual wall terminating at or before the transitionbetween the posterior and anterior regions; (3) in a barrier layerconfigured for placement over an upper dental arch, a transition portionbetween the bottom wall and the lingual wall of the barrier layer havinga radius of curvature that is larger as compared to a radius ofcurvature at a transition portion between the bottom wall and thelabial-buccal wall; or (4) in a barrier layer that is configured forplaced over a lower dental arch, a transition portion between the bottomwall and the labial-buccal wall having a radius of curvature that islarger as compared to a radius of curvature at a transition portionbetween the bottom wall and the lingual wall.

Non-custom dental tray devices including one or more of these structuralfeatures are better able to conform to the standard and natural contourof the teeth and/or gum tissue surrounding the dental arches. This isadvantageous as it reduces the presence of gaps between the barrierlayer and the tooth and/or gum tissue, which gaps can allow introductionof saliva and/or result in a looser fit of the tray over the dentalarch, all of which act to reduce the effectiveness of a dental treatmentin the case of a dental treatment tray. In the case of a mouth guard,these gap characteristics result in a fit which does not rest as closeto the tooth and gum tissue as it otherwise could, which can result in aloose fit to such a mouth guard. In a worst case, such a mouth guardmight be sufficiently loose so as to fall off, resulting in damage tothe teeth while participating in a sport.

In the case of a dental treatment tray, the barrier layer isadvantageously thin and flexible so that it can readily conform to aplurality of differently sized dental arches corresponding to differentpeople. Generally, barrier layers for devices configured as dentaltreatment trays will have a thickness less than about 2 mm, moretypically less than about 1 mm, and most preferably less than about 0.5mm. For example, according to one particularly preferred embodiment thebarrier layer has a thickness between about 0.1 and about 0.5 mm.

Mouth guards for use in sports are thicker so as to provide a cushioningeffect to the teeth and surrounding gum tissue. An exemplary mouth guardmay have a thickness greater than about 2 mm. Advantageously, it hasbeen found that incorporation of one or more of the above describedstructural features allows the barrier layer of a mouth guard to besomewhat thinner for increased comfort while still providing the samelevel of protection, cushioning, and comfort as compared to a mouthguard that does not include any of the above structural features.

A related kit advantageously includes a first dental tray device asdescribed above configured for placement over at least a portion of aperson's lower dental arch and a second dental tray device configuredfor placement over at least a portion of a person's upper dental arch.Each dental tray device includes at least one of the describedstructural features. For example, the dental tray device configured forplacement over a lower dental arch may include a bottom wall where atransition portion between the bottom wall and a labial-buccal wall hasa radius of curvature that is larger as compared to a radius ofcurvature of a transition portion between the bottom wall and a lingualwall. Likewise, the second dental tray device that is configured forplacement over an upper dental arch may advantageously include atransition portion between a bottom wall and a lingual wall that has aradius of curvature that is larger as compared to a radius of curvatureof a transition portion between the bottom wall and a labial-buccalwall.

The dental trays may further advantageously include an abrupt narrowingof the width of the bottom wall at a location corresponding to atransition portion between posterior teeth and anterior teeth (i.e.,between the first bicuspids and the canines), to account for thesignificant difference between the occlusal surface width of theposterior teeth as compared to the anterior teeth. Alternatively, one orboth dental trays may include a bottom wall which has a width in theposterior region (i.e., posterior to the first bicuspid-caninetransition) of the tray that is equal to or less than a width of thebottom wall in the anterior region of the tray, and in which the lingualwall terminates at or before the transition between the posterior andanterior regions.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by references to specific embodiments thereof, which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1A is a perspective view of an exemplary dental treatment trayconfigured to fit over at least a portion of a person's upper dentalarch, next to an associated exoskeleton;

FIG. 1B is a perspective view of an exemplary dental treatment trayconfigured to fit over at least a portion of a person's lower dentalarch, next to an associated exoskeleton;

FIG. 1C is a perspective view of another exemplary dental treatment trayconfigured to fit over at least a portion of a person's upper dentalarch, next to an associated exoskeleton;

FIG. 1D is a perspective view of another exemplary dental treatment trayconfigured to fit over at least a portion of a person' lower dentalarch, next to an associated exoskeleton;

FIG. 1E is a perspective view of an exemplary dental treatment trayconfigured to fit over at least a portion of a person's upper dentalarch, next to an optional exoskeleton,

FIG. 1F is a perspective view of an exemplary dental treatment trayconfigured to fit over at least a portion of a person's lower dentalarch, next to an optional exoskeleton, which has no lingual wall in theposterior region;

FIG. 2A is a perspective view of an exemplary mouth guard configured tofit over at least a portion of a person's upper dental arch;

FIG. 2B is a perspective view of an exemplary mouth guard configured tofit over at least a portion of a person's lower dental arch;

FIG. 3 is a perspective view of the dental treatment tray andexoskeleton of FIG. 1A with a substantially solid adhesive compositionplaced adjacent a wall of the tray;

FIG. 4 is a perspective view of the dental treatment tray andexoskeleton of FIG. 1A with a gel treatment composition placed adjacenta wall of the tray;

FIG. 5 illustrates a sealed protective package having a peelable coverthat contains the dental treatment trays and exoskeletons of FIGS. 1Aand 1B;

FIG. 6A illustrates a person placing a dental treatment tray accordingto the invention over the upper dental arch;

FIG. 6B illustrates a person having placed a dental treatment trayaccording to the invention over the lower dental arch, with a dentaltreatment tray already placed over the upper dental arch;

FIG. 7A is a close up top view of the dental treatment tray shown inFIG. 6B placed over a persons upper dental arch showing how the width ofthe bottom wall is configured to tuck into the abrupt narrowing ofocclusal width between a person's first bicuspids and canines;

FIG. 7B is a close up top view of the other dental treatment tray shownin FIG. 6B placed over a persons lower dental arch showing how the widthof the bottom wall is configured to tuck into the abrupt narrowing ofocclusal width between a person's first bicuspids and canines;

FIG. 8A is a close up cross sectional view of the dental treatment trayand upper dental arch of FIG. 7A showing that the transition portionbetween the bottom wall and the lingual wall has a radius of curvaturethat is larger than the radius of curvature of the transition portionbetween the bottom wall and the labial-buccal wall; and

FIG. 8B is a close up cross sectional view of the dental treatment trayand lower dental arch of FIG. 7B showing that the transition portionbetween the bottom wall and the labial-buccal wall has a radius ofcurvature that is larger than the radius of curvature of the transitionportion between the bottom wall and the lingual wall.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS I. INTRODUCTION ANDDEFINITIONS

The inventive non-custom tray-shaped dental tray devices include amoisture-resistant barrier layer having a labial-buccal wall, a lingualwall, and a bottom wall interposed therebetween. In addition, thetray-shaped dental treatment device includes at least one of thefollowing structural features to enhance the fit of the device over aplurality of differently-sized and/or shaped teeth without requiring anycustomization: (1) the bottom wall including an abrupt reduction of itswidth positioned to help the bottom wall better conform to abruptchanges in the occlusal surface width of a person's posterior teethversus anterior teeth; (2) a width of the bottom wall in the posteriorregion of the tray being equal to or less than a width of the bottomwall in the anterior region of the tray, and the lingual wallterminating at or before the transition between the posterior andanterior regions; (3) in a device configured for placement over a lowerdental arch, a transition portion between the bottom wall and thelabial-buccal wall having a larger radius of curvature as compared to aradius of curvature at a transition portion between the bottom wall andthe lingual wall; or (4) in a device configured for placement over anupper dental arch, a transition portion between the bottom wall and thelingual wall having a larger radius of curvature as compared to a radiusof curvature at a transition portion between the bottom wall and thelabial-buccal wall.

The tray devices may comprise a dental treatment tray (e.g., used fortooth bleaching or other treatment) or a mouth guard (e.g., used toprotect the dental arches while participating in a contact sport).Generally, dental treatment tray devices are characterized as beingrelatively thin (e.g., less than about 2 mm), while mouth guards arethicker (e.g., greater than about 2 mm).

In the context of a dental treatment tray (e.g., as used for toothbleaching), the term “barrier layer”, refers to one or more layers of amoisture-resistant material that protects a treatment composition and/oradhesive composition layer from ambient moisture and saliva found withina person's mouth when the dental treatment tray is placed over theperson's teeth. The barrier layer may also serve to protect a treatmentcomposition and/or adhesive composition from moisture or othercontaminants during storage and prior to use.

In the context of a mouth guard, the barrier layer is thicker than abarrier layer of a dental treatment tray used for tooth and/or gumtreatment (e.g., greater than about 2 mm for a mouth guard versus lessthan about 2 mm, less than about 1 mm, and most preferably between about0.5 and about 0.25 mm for a dental treatment tray). The barrier layer ofa mouth guard serves to protect the hard and soft tissue (e.g., theteeth and gums) while participating in a sport or other activity inwhich a blow to the jaw or face might otherwise damage the person'steeth. Because the barrier layer includes one or more structuralfeatures to enhance fit, the non-custom barrier layer is better able tocradle, support, and protect hard and soft tissues as compared to anon-custom barrier layer mouth guard device that does not include suchfeatures. Furthermore, because of the enhanced fit, the barrier layercan be thinner relative to a mouth guard barrier layer without thestructural features, while still providing the same level of protection.The relatively thin mouth guard barrier layer is advantageously morecomfortable than a thicker mouth guard barrier layer.

The term “gel” refers to treatment and/or adhesive compositions thathave been formulated or processed so as to be flowable, either by theforce of gravity (i.e., having no yield stress) or that do not flow bythe force of gravity but which are viscous or plastic such that they canbe shaped or manipulated (e.g., they can be expressed from a syringeorifice or other dispensing means known in the art). The term “gel”broadly encompasses a wide range of compositions having greatly varyingviscosities, although treatment and adhesive gels used with theinventive devices are preferably sufficiently thick or viscous that theywill not run out of or off of a barrier layer by gravity alone. In oneembodiment, the treatment and/or adhesive gel may be rubbery or highlyviscous. At some point, when the viscosity becomes so great as to yielda composition that is substantially solid (e.g., a stiff or highlyviscous putty), the composition may be considered to be “substantiallysolid”.

The term “substantially solid,” as used herein, refers to a composition(e.g., a treatment composition) that is in a solid or semi-solidcondition. One characteristic of “substantially solid” adhesivecompositions used with the inventive dental treatment devices is thatthey become more adhesive when an exposed surface thereof is moistenedwith, e.g., saliva or water. When moistened, the surface of the adhesivecomposition turns into a sticky material that is able to more stronglyadhere to teeth compared to a substantially solid adhesive compositionthat has not been moistened. The composition at the surface may become aviscous liquid, paste or gel, at least temporarily, depending on theamount of moisture that is applied to the surface of the “substantiallysolid” adhesive composition. Nevertheless, the consistency of themoistened surface can remain “substantially solid” depending on thedegree of initial moistening, or it can stiffen and even revert back tobeing “substantially solid” as the initial quantity of surface moisturediffuses into a remaining portion of the “substantially solid” adhesivecomposition over time (e.g., during a bleaching procedure in which thecomposition is protected from saliva and ambient moisture in a person'smouth by a moisture-resistant barrier layer).

The term “molecular weight”, as used herein, refers to number averagemolecular weight expressed in Daltons unless otherwise specified.

II. EXEMPLARY PRE-SHAPED NON-CUSTOM DENTAL TRAY DEVICES

A. Barrier Layer

The pre-shaped, non-custom dental tray devices include a barrier layer.According to one embodiment of the invention (e.g., a dental treatmenttray used for tooth bleaching and/or other treatments), the barrierlayer comprises a thin (e.g., about 2 mm or less), flexible membraneformed from a moisture-resistant polymer material. In another embodiment(e.g., a sport mouth guard), the barrier layer comprises a thicker(e.g., about 2 mm or more) flexible membrane formed from amoisture-resistant polymer material. In a preferred embodiment, thebarrier layer comprises a mixture of ethyl vinyl acetate andpolypropylene.

According to another embodiment, it may be formed of a polyolefin orsimilarly moisture-resistant material, such as wax, metal foil,paraffin, ethylene-vinyl acetate copolymer (EVA), ethylene-vinyl alcoholcopolymer (EVAL), polycaprolactone (PCL), polyvinyl chloride (PVC),polyesters, polycarbonates, polyamides, polyurethanes orpolyesteramides. Examples of suitable polyolefins for use in making thebarrier layer include, but are not limited to, polyethylene (PE), highdensity polyethylene (HDPE), low density polyethylene (LDPE), ultra lowdensity polyethylene (ULDPE), polypropylene, and polytetrafluoroethylene(PTFE) (e.g., TEFLON). An example of a suitable polyester for use inmaking the barrier layer includes, but is not limited to, polyethyleneterephthalate (PET), an example of which is MYLAR, sold by DuPont. Anexample of a suitable polyurethane barrier material is a polyurethanefilm manufactured by ArgoTech, which is located in Greenfield, Mass. Thebarrier layer may comprise a polymeric blend and/or multiple layerscomprising two or more of the foregoing materials. Plasticizers, flowadditives, and fillers known in the art can be used as desired to modifythe properties of any of the foregoing polymers used to form the barrierlayer.

According to one embodiment, the barrier layer is formed of a mixture ofethylene-vinyl acetate copolymer (EVA) and polypropylene (PP),preferably comprising about 5% to about 35% PP, more preferably about10% to about 30% PP, more especially preferably about 15% to about 25%PP, and most preferably about 20% PP, with the balance comprisingethylene-vinyl acetate (EVA), and optionally other polymers and/or smallquantities of additives such as plasticizers.

Other materials that can act as a barrier layer include cellulosicethers, cellulose acetate, polyvinyl acetate, polyvinyl alcohol,shellac, and chemical or light-cure materials (e.g., methacrylate oracrylate resins). Examples of useful cellulosic ethers that can be usedto form a barrier layer include, but are not limited to, ethylcellulose, propyl cellulose, isopropyl cellulose, butyl cellulose,t-butyl cellulose, and the like.

In general, the thickness of the barrier layer can be selected to yielda dental treatment tray or mouth guard having a desired level ofstrength, rigidity, resilience, and flexibility. In the case of a dentaltreatment tray, it is desirable for the barrier layer to be sufficientlyflexible so as to conform to a person's teeth as a result of adhesiveaction by the treatment composition and/or adhesive composition. Assuch, the barrier layer will preferably have a thickness ranging fromabout 0.025 mm to about 2 mm, more preferably in a range of about 0.05mm to about 1 mm, and most preferably in a range of about 0.1 mm toabout 0.5 mm.

In the case of a sport mouth guard, the balance between a desired degreeof flexibility and comfort versus strength, resilience, and cushioningability result in a barrier layer that is relatively thicker, preferablyhaving a thickness ranging from about 2 mm to about 5 mm, morepreferably from about 2 mm to about 4 mm, and most preferably from about2 mm to about 3 mm. Because the barrier layer includes one or morestructural features to enhance fit, less thickness is required for anygiven level of protection and cushioning ability relative to a mouthguard that does not include any of the structural features. This allowsfor use of a thinner mouth guard, which is also more comfortable to wearfor the user.

B. Dental Treatment Compositions

In the case of a dental treatment tray used for whitening or otherwisetreating a person's teeth and/or gums, a dental treatment compositionmay be applied adjacent one or more of the walls of the tray device. Thetreatment compositions may comprise any dental treatment compositionknown in the art. The treatment composition may comprise a stickyviscous gel, a less viscous gel, a highly viscous putty, or asubstantially solid adhesive composition that is less adhesive prior tobeing moistened with saliva or water but that becomes more sticky andadhesive when moistened. The treatment compositions may comprise acontinuous layer or bead positioned so as to cover a person's fronttooth surfaces, rear tooth surfaces, or both, or they may compriseseparate beads, layers or islands separated by one or more spaces. Thetreatment composition is advantageously positioned directly adjacent tothe barrier layer.

In general, dental treatment gels will include at least one dentaltreatment agent, at least one tissue adhesion (or thickening) agent, anda liquid or gel, solvent, carrier, or vehicle into which the dentaltreatment agent and tissue adhesion agent are dispersed. The treatmentgel may optionally include other active agents (e.g., desensitizingagents, remineralizing agents, antimicrobial agents, and the like), aswell as inert ingredients (e.g., plasticizers, humectants, neutralizingagents, thickening agents, flavorants, sweeteners, and the like).

Exemplary dental treatment gels, and methods for making such gels, whichmay be used with devices according to the invention are disclosed inU.S. Pat. No. 5,376,006; U.S. Pat. No. 5,785,527; U.S. Pat. No.5,851,512; U.S. Pat. No. 5,858,332; U.S. Pat. No. 5,985,249; U.S. Pat.No. 6,306,370; U.S. Pat. No. 6,309,625; U.S. Pat. No. 6,312,671; U.S.Pat. No. 6,322,774; U.S. Pat. No. 6,368,576; U.S. Pat. No. 6,387,353;U.S. Pat. No. 6,500,408; U.S. Pat. No. 6,503,485 and U.S. patentapplication Ser. No. 11/460,016 filed Jul. 26, 2006. For purposes ofdisclosing dental treatment gels, and methods of making such gels, theforegoing patents and application are incorporated herein by reference.

Following are preferred treatment agents, tissue adhesion agents,solvents or carriers, and other components within preferred treatmentcompositions that can be used within the inventive dental treatmentdevices.

1. Treatment Agents

Any treatment agent capable of treating teeth can be used. Examplesinclude dental bleaching agents, desensitizing agents, antimicrobialagents, anticariogenic agents, and the like. A common dental bleachingagent that is known to bleach teeth and that has been found to be safefor oral use is hydrogen peroxide. However, stable hydrogen peroxidedoes not itself exist free in nature, but as an aqueous solution or acomplex. Aqueous hydrogen peroxide is an acceptable dental treatmentagent to the extent that an anhydrous treatment composition is notdesired. Non-limiting examples of hydrogen peroxide complexes includecarbamide peroxide and metal perborates (e.g., sodium perborate). Otherbleaching agents that can be used to bleach teeth include, but are notlimited to, metal percarbonates (e.g., sodium percarbonate), metalperoxides (e.g., calcium peroxide), metal chlorites and hypochlorites,peroxy acids (e.g., peroxyacetic acid), and peroxy acid salts.

The bleaching agent can have any desired concentration, e.g., betweenabout 1-90% by weight of the treatment composition. The concentration ofthe dental bleaching agent can be adjusted depending on the intendedtreatment time for each treatment session. In general, the shorter thetreatment time, the more bleaching agent will be added to acceleratedental bleaching so as to effect treatment in a shorter time period. Theone or more bleaching agents are preferably included in an amount in arange of about 1% to about 60% by weight of the dental bleachingcomposition, more preferably in a range of about 5% to about 40% byweight, and most preferably in a range of about 10% to about 30% byweight.

The treatment composition may include one or more other active agentsinstead of, or in addition to, a bleaching agent to yield treatmentcompositions having desired properties. Examples of other active agentsinclude, but are not limited to, desensitizing agents (e.g., potassiumnitrate, other potassium salts, citric acid, citrates, and sodiumfluoride), remineralizing agents (e.g., sodium fluoride, stannousfluoride, sodium monofluorophosphate, and other fluoride salts),antimicrobial agents (e.g., chlorhexidine, troclosan, and tetracycline),antiplaque agents, anti-tartar agents (e.g., pyrophosphates salts), andother medicaments. Such active agents may be included in amountscustomary in the art of dental treatments.

2. Tissue Adhesion Agents

Useful tissue adhesion agents (or tackifying agents), which can also actas thickening agents that increase the viscosity of the dental treatmentcomposition (e.g., a gel, a putty, or a substantially solid adhesivecomposition), include a wide variety of hydrophilic polymers. Examplesof hydrophilic polymer tissue adhesion agents include, but are notlimited to, polyvinyl pyrrolidone (PVP), PVP-vinyl acetate copolymers,carboxypolymethylene (e.g., CARBOPOL, sold by Novean, Inc.),polyethylene oxide (e.g., POLYOX, made by Union Carbide), polyacrylicacid polymers or copolymers (e.g., PEMULEN, sold by Novean, Inc.),polyacrylates, polyacrylamides, copolymers of polyacrylic acid andpolyacrylamide, carboxymethylcellulose, carboxypropylcellulose,cellulosic ethers, polysaccharide gums, proteins, and the like.

Non-limiting examples of polyvinyl pyrrolidone polymers that have beenused in formulating dental treatment compositions include Kollidon 30, apolyvinyl pyrrolidone polymer sold by BASF having a molecular weight of50,000, Kollidon VA 60, a polyvinyl pyrrolidone polymer having amolecular weight of 60,000, and Kollidon 90 F, a polyvinyl pyrrolidonepolymer having a molecular weight of 1.3 million.

The treatment composition can be a gel, a putty, or substantially solid.The main difference between a composition that is a “gel” or“substantially solid” is the level of solvent or carrier within thecomposition. In general, the greater the concentration of solvent orcarrier relative to the tissue adhesive agent, the less viscous the gel.The lower the concentration of solvent or carrier relative to the tissueadhesion agent, the more viscous the gel. At some point, the ratio ofsolvent or carrier to tissue adhesion agent is low enough so that thecomposition is or becomes a stiff or highly viscous putty, which may becharacterized as being “substantially solid”. Stiff putties preferablybecome more adhesive to teeth when moistened with water or saliva.Substantially solid adhesive compositions can have so little solvent orcarrier as to feel dry to the touch and be initially non-adhesive butthen become adhesive to teeth when moistened with water or saliva.Substantially solid adhesive compositions can be made by initiallyincluding a very small amount of solvent or carrier and/or by firstforming an adhesive gel that is later dried to remove a substantialportion of the solvent or carrier.

Examples of substantially solid adhesive compositions that can be usedto reliably maintain a barrier layer against a person's tooth surfacesare disclosed in U.S. Pat. No. 7,059,857; U.S. Pat. No. 7,056,118; andU.S. Pat. No. 7,052,275. For purposes of disclosing substantially solidadhesive compositions, the foregoing patents are incorporated herein byreference. Examples of adhesive gel compositions are disclosed in U.S.Pat. No. 5,770,182; U.S. Pat. No. 5,855,870; U.S. Pat. No. 5,851,512;U.S. Pat. No. 55,985,249; and U.S. Pat. No. 6,036,943. For purposes ofdisclosing adhesive gel compositions, the foregoing patents areincorporated herein by reference.

To form a gel having a desired rheology, the one or more tissue adhesionagents are preferably included in an amount in a range of about 1% toabout 50% by weight of the dental treatment gel, more preferably in arange of about 3% to about 30% by weight, and most preferably in a rangeof about 5% to about 20% by weight. In the case where the treatmentcomposition is substantially solid, the one or more tissue adhesionagents are preferably included in an amount in a range of about 10% toabout 90% by weight of the substantially solid adhesive composition,more preferably in a range of about 20% to about 80% by weight, and mostpreferably in a range of about 40% to about 75% by weight.

In one embodiment, a dental treatment tray includes a layer or region ofa substantially solid adhesive composition, and a treatment gel or puttyadjacent to the barrier layer and/or the adhesive composition. Theadhesive composition may be formulated to provide the same treatment asthe separate gel or putty treatment composition, a different treatment,or no treatment. It may provide a protective barrier between thetreatment agent in the gel or putty and the person's relativelysensitive gum tissue. It may include a bleaching agent activator in thecase where the gel or putty includes a bleaching agent. Additionaldetails regarding such configurations are disclosed in U.S. patentapplication Ser. No. 11/474,759 filed Jun. 26, 2006, herein incorporatedby reference.

3. Carriers and Vehicles

Dental treatment gels for use with dental treatment trays according tothe invention will typically include one or more liquid or gel solvents,carriers, or vehicles into which the dental treatment agent, tissueadhesion agent, and other components are dissolved or dispersed. Thesolvent, carrier, or vehicle will typically comprise the balance ofcomponents in the dental treatment gel in addition to the treatmentagent, tissue adhesion agent, and other components.

Examples of liquid or gel solvents, carriers or vehicles include, butare not limited to, water, alcohols (e.g., ethyl alcohol), and polyols(e.g., glycerin, sorbitol, mannitol, other sugar alcohols, propyleneglycol, 1,3-propanediol, polyethylene glycol, polyethylene oxide, andpolypropylene glycol).

4. Other Components

The treatment compositions may optionally include other components asdesired to yield treatment compositions having desired properties.Examples include bleaching agent stabilizers (e.g., EDTA, salts of EDTA,citric acid and its salts, phosphoric acid and its salts,phenolphosphonic acid and its salts, gluconic acid and its salts, alkalimetal pyrophosphates, alkali metal pyrophosphates, alkyl sulfates, suchas sodium lauryl sulfate, tin salts, such as sodium starnate, andtartrates), neutralizing agents (e.g., sodium hydroxide andtriethanolamine), humectants, flavorants, sweeteners, inorganicrheology-modifying agents (e.g., fumed silica), and the like. Exemplarydental bleaching compositions including an inorganic rheology-modifyingagent in addition to a generally linear high molecular weight (i.e.,greater than about 500,000) polyvinyl pyrrolidone (PVP) and/orpolyethylene oxide (PEO) tissue adhesion agent are disclosed in U.S.patent application Ser. No. 11/460,016 filed Jul. 26, 2006, hereinincorporated by reference.

C. Characteristics of Pre-Shaped Non-Custom Dental Tray Devices

The pre-shaped, non-custom dental tray devices according to theinvention are advantageously in the shape of a dental tray having alabial-buccal wall, a lingual wall, and a bottom wall interposed betweenthe labial-buccal wall and the lingual wall. The three walls define aninterior trough configured to receive at least a portion of a person'sdental arch. The basic tray shape of the device facilitates placement ofthe device over a person's teeth by reducing the amount of manipulationnecessary to obtain a good fit between the device and the person'steeth. The tray is non-custom. In other words, it is substantiallydevoid of structures corresponding to the size and shape of a person'sunique dentition so that the tray devices are designed to comfortablyfit over a plurality of differently-sized and/or shaped teethcorresponding to different people.

The pre-shaped non-custom dental tray devices include at least one, andpreferably two of the following structural features to enhance theability of the device to conform to the patient's teeth withoutcustomization: (1) the bottom wall includes an abrupt reduction of widthpositioned at a location corresponding to a transition between posteriorteeth and anterior teeth to account for a significant difference betweenthe occlusal surface width of a person's posterior teeth as compared tothe person's anterior teeth; (2) in a device configured for placementover a lower dental arch, a transition portion between the bottom walland the labial-buccal wall has a larger radius of curvature as comparedto a radius of curvature at a transition portion between the bottom walland the lingual wall; and (3) in a device configured for placement overan upper dental arch, a transition portion between the bottom wall andthe lingual wall has a larger radius of curvature as compared to aradius of curvature at a transition portion between the bottom wall andthe labial-buccal wall.

FIG. 1A illustrates a perspective view of an exemplary pre-shaped,non-custom dental treatment tray 100, along with an associatedexoskeleton 100 a having a handle 103 a. The treatment tray 100 of FIG.1A is sized and configured for placement over a person's upper dentalarch. Device 100 comprises a moisture resistant barrier layer 101 havinga labial-buccal wall 102, a bottom wall 104, and a lingual wall 106.

The bottom wall 104 includes an abrupt reduction in width positioned atlocations 108 corresponding to a transition between posterior teeth(i.e., bicuspids and molars) and anterior teeth (i.e., canines andincisors). Because there is a significant difference in occlusal surfacewidth of the posterior teeth relative to the anterior teeth,particularly between the first bicuspid and the canine, an abruptreduction in bottom wall width at a location of the barrier layercorresponding to the transition from the first bicuspid to the caninehelps the bottom wall 104 and the lingual wall 106 to better conform tothe teeth in this area. In other words, the sharp and abrupt reductionof width of the bottom wall 104 helps to compensate for the fact thatbicuspids are significantly thicker than canines by allowing for anabrupt narrowing of the bottom wall 104 of the treatment device 100.

Without this narrowing of the bottom wall, it would be much moredifficult to conform the bottom wall 104 to the canines since theadjacent bicuspids would tend to push the bottom wall 104 away from thecanines, potentially dislodging the bottom wall 104 in this region.Because the bottom wall is continuous, rather than including one or morecuts at locations 108, little or no manipulation and forming of thebarrier layer is required when fitting the treatment tray 100 over thedental arch. Advantageously, the treatment tray is simply aligned withthe dental arch so that narrowing locations 108 of the bottom wall areinserted between the first bicuspids and the canines on each side of thedental arch (see FIGS. 7A-7B). In addition, it has been found that theuse of cuts or discontinuities within bottom wall 104 at locations 108may allow the patient's tongue to lodge between the dental arch and thebarrier layer, lifting the tray off the dental arch. Because the bottomwall is continuous, there is reduced risk that the treatment and/oradhesive composition will be exposed to saliva or disruption from directcontact with the tongue during treatment, as could potentially occur ifthere were cuts or discontinuities within the bottom wall.

Bottom wall 104 has the greatest width across the portion intended toreceive bicuspids and/or molars near region 109 which has a widthbetween about 8 mm and about 12 mm (e.g., about 10 mm). At location 108the width narrows abruptly (e.g., within a distance of about 3 mm orless) to a width between about 1 mm and about 3 mm (e.g., about 1.5 mm).Described another way, the width of bottom wall 104 is reduced betweenabout 60 percent and about 95 percent, more preferably between about 75percent and about 90 percent, and most preferably between about 80percent and about 90 percent. These ranges have been found to provide agood fit for the majority of adult upper dental arches.

The posterior portion (e.g., near regions 109) of bottom wall 104 andlingual wall 106 includes a transition portion between bottom wall 104and lingual wall 106 where the radius of curvature at the transitionportion is greater than the radius of curvature at a transition portionbetween bottom wall 104 and labial-buccal wall 102. This difference incurvature on the lingual side versus the labial-buccal side of the trayaccounts for the difference in angulation and orientation of the teeth,particularly the posterior teeth, on the lingual tooth surfaces versusthe labial-buccal tooth surfaces. These curvature configurations allowthe non-custom tray to better conform to the upper dental arch.Additional details of the configuration of the transition area betweenthe bottom wall 104 and the lingual wall 106 as compared to thetransition area between the bottom wall 104 and the labial-buccal wall104 will be further described below in conjunction with FIG. 8A.

In addition, the posterior portion of lingual wall 106 mayadvantageously include an “S” type curve to advantageously provide amore comfortable fit against lingual gum tissue adjacent the posteriorteeth of the upper dental arch. In other words, at a posterior portion,lingual wall 106 is configured to have a relatively steep angle (e.g.,about 90° to about 110°) relative to bottom wall 104 immediatelyadjacent to a transition from bottom wall 104 to lingual wall 106, andpart way up lingual wall 106 there is an inflection line or region, suchthat the extreme upper posterior portion 107 of lingual wall 106 isflared in a lingual direction so as to have a more open angle relativeto bottom wall 104 (e.g., about 120° to about 140°) so as to fit morecomfortably against the lingual gum tissue adjacent to the upper dentalarch. The lingual gum tissue adjacent the upper dental arch (i.e., alongthe roof of the mouth) generally exhibits a relatively more gentlesloping surface as compared to the labial gum tissue, as well as thelingual gum tissue adjacent the lower dental arch, which is generallynearly parallel to the labial and lingual surfaces of the teeth. Such an“S” type curve is particularly helpful within a device configured foruse over the upper dental arch, as it is only the lingual gum tissueadjacent the upper dental arch that exhibits such a gentle slopingsurface. In other words, the lingual gum tissue adjacent the lowerdental arch slopes away from the dental arch at a much steeper surfaceslope, such that an “S” type curve within lingual wall 106′ (FIG. 1B) isnot necessary, although it is within the scope of the invention toprovide such a curve in lingual wall 106′ of the lower dental treatmenttray 100′.

As illustrated, the bottom wall may advantageously include a notch 110near the front of bottom wall 104 of treatment tray 100. Optional notch110 allows the non-custom dental treatment tray 100 to more easilyspread open or compress in the area of the incisors. This is helpful inallowing the bottom wall 104 of the non-custom tray to more easilyconform to differently-sized dental arches. As illustrated, notch 110may have rounded exterior corners.

In the illustrated embodiment, the bottom wall 104 also advantageouslyincludes two V-shaped indentations 112 configured to be inserted intothe depression typically found along the top surfaces of a person's leftand right posterior teeth (e.g., bicuspids and/or molars. Such a featureprovides a dental tray device that better conforms to the person'steeth, resulting in a more comfortable fit, as further illustrated inFIGS. 8A-8B.

FIG. 1B illustrates a perspective view of an exemplary dental treatmenttray 100′ along with an associated exoskeleton 100 a′ having a handle103 a′. The pre-shaped non-custom dental treatment tray 100′ is sizedand configured for placement over a person's lower dental arch. Thenon-custom dental treatment tray 100′ includes a barrier layer 101′ ofmoisture resistant material having a labial-buccal wall 102′, a lingualwall 106′, and a bottom wall 104′. Bottom wall 104′ abruptly narrows inwidth at location 108′, which corresponds to the transition from theposterior teeth (e.g., bicuspids and molars) to the anterior teeth(e.g., canines and incisors), which anterior teeth have a significantlysmaller occlusal surface width and diameter as compared to the posteriorteeth. Bottom wall 104′ further includes an optional notch 110′ and twoV-shaped indentations 112′.

Bottom wall 104′ preferably has its greatest width across the portionintended to receive bicuspids and/or molars near region 109′, which hasa width between about 7 mm and about 11 mm (e.g., about 9 mm). Atlocation 108′ the width narrows abruptly (e.g., within a distance ofabout 4 mm or less) to a width between about 1 mm and about 4 mm (e.g.,about 2.5 mm). Described another way, at location 108′ the width ofbottom wall 104′ is reduced between about 40 percent and about 90percent, more preferably between about 50 percent and about 85 percent,and most preferably between about 60 percent and about 80 percent. Theseranges have been found to provide a good fit for the majority of adultlower dental arches.

It is noted that the narrowing of bottom wall 104′ of device 100′ is notas pronounced or abrupt as in device 100 configured for placement overthe upper dental arch. This is a result of general differences in theocclusal surface width between teeth of the upper dental arch relativeto differences between teeth of the lower dental arch. The upperincisors are generally oriented more vertically relative to the occlusalplane than the lower incisors, which tend to be flared outward at agreater angle relative to a horizontal occlusal plane (e.g., about 87°versus about 78°). Providing the lower tray with a slightly wider bottomwall (e.g., about 2.5 mm) than the bottom wall of the upper tray (e.g.,about 1.5 mm) has been found to improve the ease with which a variety ofusers are able to install the tray over the dental arch. For example, itis fairly common for the lower incisors to be somewhat crowded ortwisted, for which the wider bottom wall is helpful. Devices of somewhatdifferent geometries specifically configured for use over the upper orlower dental arches provide for much improved fit as compared to onlyproviding a single device for use over both the upper dental arch aswell as over the lower dental arch.

The posterior portion (e.g., near regions 109′) of bottom wall 104′ andlabial-buccal wall 102′ includes a transition portion between bottomwall 104′ and labial-buccal wall 102′ where the radius of curvature atthe transition portion is greater than the radius of curvature at atransition portion between bottom wall 104′ and lingual wall 106′. Thisdifference in curvature on the lingual side versus the labial-buccalside of the tray accounts for the difference in angulation andorientation of the teeth, particularly the posterior teeth, on thelabial-buccal tooth surfaces versus the lingual tooth surfaces. Thesecurvature configurations allow the non-custom tray to better conform tothe lower dental arch. Additional details of the configuration of thetransition area between the bottom wall 104′ and the labial-buccal wall102′ as compared to the transition area between the bottom wall 104′ andthe lingual wall 106′ will be further described below in conjunctionwith FIG. 8B.

FIGS. 1C-1D illustrate alternative dental treatment tray devices 700 and700′ configured for placement over the upper and lower dental arches,respectively. Each dental treatment tray device 700 and 700′ isillustrated next to an associated support skeleton (700 a and 700 a′,respectively). Dental treatment tray 700 is similar to dental treatmenttray 100 in that it is configured for placement over a person's upperdental arch. Dental treatment tray 700 includes a barrier layer 701, alabial-buccal wall 702, a bottom wall 704, a lingual wall 706, and anotch 710. A principal difference between tray 700 and tray 100 is thatlingual wall 706 terminates near (e.g., at or before) location 708. Inother words, lingual wall 706 extends along the anterior portion of thetray so that wall 706 will be positioned adjacent to the anterior teethduring use, but no lingual coverage is provided to the posterior teethbecause of the early termination of lingual wall 706. In addition theposterior portion 709 of bottom wall 704 may not be as wide as analogouswall 104 of tray 100. In other words, a posterior portion of lingualwall 706 and optionally a part of a posterior portion of bottom wall 704may be cut away relative to tray 100 of FIG. 1A.

At locations 708, bottom wall 704 abruptly narrows. Locations 708advantageously correspond to a transition from the posterior teeth(i.e., molars and bicuspids) to the anterior teeth (i.e., canines andincisors). If a portion of the posterior part of bottom wall 704 is cutaway relative to tray 100 of FIG. 1A, the narrowing of bottom wall 704may not be so pronounced as that of tray 100, although the narrowing ofbottom wall 704 is still evident as seen in FIG. 1C. The effect of suchan embodiment is that an enhanced, close fit is still provided at thetransition from posterior teeth to anterior teeth, although the bottomwall may not cover the full occlusal surface width of the posteriorteeth (i.e., because it has been narrowed relative to bottom wall 104 oftray 100). It has been found that an embodiment as illustrated in FIG.1C may facilitate easier manipulation and positioning of the tray, as itis not necessary to manipulate or position a posterior portion oflingual wall 706 against the lingual side of the dental arch. Althoughthe lingual wall 706 terminates so as to not cover the posterior teeth,the abrupt narrowing in the width of the bottom wall at a locationcorresponding to the transition from posterior to anterior teeth stillresults in an enhanced, closer fit and increased comfort when using thenon-custom dental treatment tray as compared to a tray that does notinclude such an abrupt narrowing.

As seen in FIG. 1C, support skeleton 700 a may be identical to supportskeleton 100 a of FIG. 1A. Alternatively, skeleton 700 a may beconfigured as tray 700 with a terminated lingual wall and optionally abottom wall that is also narrowed in a region corresponding to theposterior teeth. Providing a skeleton that includes a full length,non-terminated lingual wall and a full width bottom wall is usefulduring placement of tray 700 as it provides for better support tofacilitate better control when positioning tray 700 over the upperdental arch.

Dental treatment tray 700′ is similar to dental treatment tray 100′ inthat it is configured for placement over a person's lower dental arch.Dental treatment tray 700′ includes a barrier layer 701′, alabial-buccal wall 702′, a bottom wall 704′, a lingual wall 706′, and anotch 710′. A principal difference between tray 700′ and tray 100′ isthat lingual wall 706′ terminates near (e.g., at or before) location708′. In other words, lingual wall 706′ extends along the anteriorportion of the tray so that wall 706′ will be positioned adjacent to theanterior teeth during use, but no lingual coverage is provided to theposterior teeth because of the early termination of lingual wall 706′.In addition, the posterior portion 709′ of bottom wall 704′ may not beas wide as analogous wall 104′ of tray 100′. In other words, a posteriorportion of lingual wall 706′ and optionally a part of a posteriorportion of bottom wall 704′ may be cut away relative to tray 100′ ofFIG. 1B.

At locations 708′, bottom wall 704′ abruptly narrows. Locations 708′advantageously correspond to a transition from the posterior teeth(i.e., molars and bicuspids) to the anterior teeth (i.e., canines andincisors). If a portion of the posterior part of bottom wall 704′ is cutaway relative to tray 100′ of FIG. 1B, the narrowing of bottom wall 704′may not be so pronounced as that of tray 100′, although the narrowing ofbottom wall 704′ is still evident as seen in FIG. 1D. The effect of suchan embodiment is that an enhanced, close fit is still provided at thetransition from posterior teeth to anterior teeth, although the bottomwall may not cover the full occlusal surface width of the posteriorteeth (i.e., because it has been narrowed relative to bottom wall 104′of tray 100′). It has been found that an embodiment as illustrated inFIG. 1D may facilitate easier manipulation and positioning of the tray,as it is not necessary to manipulate or position a posterior portion oflingual wall 706′ against the lingual side of the dental arch. Althoughthe lingual wall 706 terminates so as to not cover the posterior teeth,the abrupt narrowing in the width of the bottom wall at a locationcorresponding to the transition from posterior to anterior teeth stillresults in an enhanced, closer fit and increased comfort when using thenon-custom dental treatment tray as compared to a tray that does notinclude such an abrupt narrowing.

As seen in FIG. 1D, support skeleton 700 a′ may be identical to supportskeleton 100 a′ of FIG. 1B. Alternatively, skeleton 700 a′ may beconfigured as tray 700′ with a terminated lingual wall and optionally abottom wall that is also narrowed in a region corresponding to theposterior teeth. Providing a skeleton that includes a full length,non-terminated lingual wall and a full width bottom wall is usefulduring placement of tray 700′ as it provides for better support tofacilitate better control when positioning tray 700′ over the lowerdental arch.

FIGS. 1E-1F illustrate alternative dental treatment tray devices 800 and800′ configured for placement over the upper and lower dental arches,respectively. Each dental treatment tray device 800 and 800′ isillustrated next to an optional associated support skeleton (800 a and800 a′, respectively). Dental treatment tray 800 is similar to dentaltreatment tray 700 in that it is configured for placement over aperson's upper dental arch. Dental treatment tray 800 includes a barrierlayer 801, a labial-buccal wall 802, a bottom wall 804, a lingual wall806, and a notch 810. Lingual wall 806 terminates at or before location808 (e.g., corresponding to a location where the canine and firstbicuspid meet). In other words, lingual wall 806 extends along theanterior region 811 of the tray 800 so that wall 806 will be positionedadjacent to the anterior teeth during use, but no lingual wall ispresent along the posterior region 809 of the tray because of the earlytermination of lingual wall 806.

A principal difference between tray 800 and tray 700 of FIG. 1C is thatthe width of bottom wall 804 within posterior portion 809 is typicallyless than or equal to the width of bottom wall 804 within anteriorregion 811 (e.g., nearly all of bottom wall 804 may be cut away relativeto trays 100 and 700 of FIGS. 1A and 1C, respectively), as it may not benecessary or desirable to treat the occlusal and labial surfaces of theposterior teeth. Such a configuration reduces the tray wall surface areathat must be kept adjacent to and adhered to the posterior teeth duringtreatment, as there is no labial wall in the posterior portion 809, andthe surface area of bottom wall 804 within posterior portion 809 isgreatly reduced relative to illustrated trays 100 and 700.

Although there is no abrupt width reduction in bottom wall 804 as intrays 100 and 700, a similar result of enhanced comfort and fit is stillachieved. A principal purpose of reducing the bottom wall width attransition location 108 (see FIG. 1A) is to provide a bottom wall withinthe anterior region which is relatively narrow so as to be tailored tothe occlusal width of the anterior teeth and a bottom wall within theposterior region which is substantially wider so as to be tailored tothe occlusal width of the posterior teeth, although the wider width ofthe bottom wall within the posterior region may be absent, along withthe posterior portion of the lingual wall, and achieve better non-customfit. In tray 100, the transition between narrow and wide width occursabruptly at location 108 (e.g., between the first bicuspid and thecanine). Because the bottom wall snugly fits the occlusal width of boththe anterior and posterior regions of the dental arch, pressure appliedto the bottom wall within either region does not result in a pulling offof another portion of the bottom wall, which may otherwise be expectedto occur if the bottom wall width were not configured to snugly fit theocclusal surface of the dental arch. Forming the tray such that thelingual wall and a substantial portion of the bottom wall are absentwithin the posterior region of the tray does not alter the ability ofthe remaining surfaces of the tray (i.e., the labial wall and theremaining portions of the bottom wall) to snugly fit against the labialand a portion of the occlusal tooth surfaces of the dental arch. Infact, it may further enhance fit even though the tray is non-custom byvirtually eliminating the possibility of poor fit between the tray and aperson's posterior teeth.

In this embodiment it is the actual width (which is relatively narrowrelative to the occlusal tooth surfaces of the posterior teeth) of thebottom wall along the anterior region and at transition location 808 incombination with providing a lingual wall which terminates at or beforelocation 808 that is important to the tray's ability to snugly fit overthe dental arch. For example, bottom wall 804 has a width at location808 which is between about 1 mm and about 3 mm (e.g., about 1.5 mm).This narrow width continues throughout the anterior region 811 of thetray so as to accommodate the occlusal surface width of the incisors.Rather than abruptly widening posterior to location 808, the width mayremain substantially equal to the width at location 808 and anteriorthereto, or even be further reduced such that the posterior portion ofbottom wall 804 only covers a small portion of the occlusal surface ofthe posterior bicuspids and molars along the occlusal-labial edge of thedental arch. In such an embodiment, the narrow remaining portion ofbottom wall 804 in the posterior region of tray 800 may simply act as aguide and anchor to aid in aligning the tray 800 over the dental arch,as little or no treatment of the posterior occlusal tooth surfaces isprovided by such a tray 800. The posterior portion of bottom wall 804laterally extends from labial wall 802 so as to act as a guide andanchor to the posterior portion of labial wall 802, which covers thelabial tooth surfaces of the dental arch.

Similar to the embodiment illustrated in FIG. 1C, upper tray 800 mayfacilitate easier manipulation and positioning of the tray, as it is notnecessary to manipulate or position a posterior portion of a lingualwall against the lingual side of the dental arch. Although lingual wall806 terminates at or before location 808 so as to not cover theposterior teeth, the overall narrow width of bottom wall 804 along theanterior region 811 of the tray and up to location 808 still results inan enhanced, close, snug fit with increased comfort when using thenon-custom dental treatment tray as compared to existing non-custom traydesigns. The presence of lingual wall 806 along anterior region 811 andits absence within posterior region 809 further aids in providing a snugfit of the tray 800 against the occlusal tooth surfaces of the dentalarch.

Referring to FIG. 1F, dental treatment tray 800′ is similar to dentaltreatment tray 700′ in that it is configured for placement over aperson's lower dental arch. Dental treatment tray 800′ includes abarrier layer 801′, a labial-buccal wall 802′, a bottom wall 804′, alingual wall 806′ within the anterior region 811′ of the tray, and anotch 810′. Similar to tray 800, lingual wall 806′ terminates at or nearlocation 808′. In other words, lingual wall 806′ extends along theanterior region 811′ of the tray so that wall 806′ will be positionedadjacent to the anterior teeth during use, but no lingual coverage isprovided to the posterior teeth because of the early termination oflingual wall 806′. Also similarly, bottom wall 804′ may have itsposterior portion cut away or otherwise absent relative to tray 700′ ofFIG. 1D so that the width of bottom wall 804′ within posterior region809′ is less than or equal to the width of bottom wall 804′ withinanterior region 811′ (e.g., nearly all of bottom wall 804′ may be cutaway relative to trays 100′ and 700′ of FIGS. 1B and 1D, respectively),as it may not be necessary or desirable to treat the occlusal and labialsurfaces of posterior teeth. Such a configuration reduces the tray wallsurface area that must be kept adjacent to and adhered to the posteriorteeth during treatment, as there is no labial wall in the posteriorportion 809′, and the surface area of bottom wall within posteriorportion 809′ is greatly reduced relative to illustrated trays 100′ and700′.

Although there is no abrupt width reduction in bottom wall 804′ as intrays 100′ and 700′, a similar result of enhanced comfort and fit isstill achieved. As described above, a principal purpose of reducing thebottom wall width at transition location 108′ (see FIG. 1B) is toprovide a bottom wall within the anterior region of the tray which isrelatively narrow so as to be tailored to the occlusal width of theanterior teeth and a bottom wall within the posterior region which issubstantially wider so as to be tailored to the occlusal width of theposterior teeth. The transition between narrow and wide width occursabruptly at location 108′ (e.g., between the first bicuspid and thecanine). Because the bottom wall snugly fits the occlusal width of boththe anterior and posterior regions of the dental arch, pressure appliedto the bottom wall within either region does not result in a pulling offof another portion of the bottom wall, which may otherwise be expectedto occur if the bottom wall width were not configured to snugly fit theocclusal surface of the dental arch. Removing the lingual wall and asubstantial portion of the bottom wall within the posterior region 809′of the tray does not alter the ability of the remaining surfaces of thetray 800′ (i.e., the labial wall and the remaining portions of thebottom wall) to snugly fit against the labial and a portion of theocclusal tooth surfaces of the dental arch.

In other words, in such an embodiment it is the actual width (which isrelatively narrow relative to the occlusal tooth surfaces of theposterior teeth) of the bottom wall along the anterior region 811′ andat transition location 808′ in combination with providing a lingual wallwhich terminates at or near location 808′ that is important to thetray's ability to snugly fit over the dental arch. For example, bottomwall 804′ has a width at location 808′ which is between about 1 mm andabout 4 mm (e.g., about 2.5 mm). This narrow width continues throughoutthe anterior region 811′ of the tray so as to snugly accommodate theocclusal surface width of the incisors. Rather than abruptly wideningposterior to location 808′, the width may remain substantially equal tothe width at location 808′ and anterior thereto, or be even furtherreduced such that the posterior portion of bottom wall 804′ only coversa small portion of the occlusal surface of the posterior bicuspids andmolars along the occlusal-labial edge of the dental arch. In such anembodiment, the narrow remaining portion of bottom wall 804′ in theposterior region of tray 800′ may simply act as a guide and anchor toaid in aligning the labial wall 802′ over the posterior portion of thelabial tooth surfaces of the dental arch.

As seen in FIGS. 1E-1F, optional support skeletons 800 a and 800 a′ mayinclude a configuration similar to trays 800 and 800′, respectively,including a terminated lingual wall and a bottom wall which has been cutaway within the posterior region so as to not cover most of theposterior occlusal tooth surfaces.

FIGS. 2A-2B illustrate a set of mouth guards 200 and 200′. Mouth guard200, similar to dental treatment tray 100, is configured for placementover a person's upper dental arch, while mouth guard 200′ is configuredfor placement over a person's lower dental arch. Mouth guard 200includes a barrier layer 201, a labial-buccal wall 202, a bottom wall204, a lingual wall 206, a notch 210, and a pair of V-shapedindentations 212. At locations 208, bottom wall 204 abruptly narrows.Location 208 advantageously corresponds to a transition from theposterior teeth (i.e., molars and bicuspids) to the anterior teeth(i.e., canines and incisors). Because the posterior teeth have asignificantly greater occlusal surface width or thickness as compared tothe anterior teeth, abruptly narrowing the width of the bottom wall at alocation corresponding to this transition results in an enhanced, closerfit and increased comfort when using the non-custom mouth guard. Inaddition, the radius of curvature along a transition portion between aposterior portion of bottom wall 204 and a posterior portion of lingualwall 206 is advantageously greater than the radius of curvature along atransition portion between a posterior portion of bottom wall 204 and aposterior portion of labial-buccal wall 202.

Mouth guard 200′ of FIG. 2B is similar to dental treatment tray 100′ asit is configured for placement over a person's lower dental arch. Mouthguard 200′ includes a barrier layer 201′, a labial-buccal wall 202′, abottom wall 204′, a lingual wall 206′, a notch 210′, and a pair ofV-shaped indentations 212′. At locations 208′, bottom wall 204′advantageously abruptly narrows to result in an enhanced, closer, andmore comfortable fit to the dental arch in the area of the firstbicuspids and the canines. Along the posterior portion of mouth guard200′, the radius of curvature along a transition portion between bottomwall 204′ and labial-buccal wall 202′ is advantageously greater than theradius of curvature at a transition portion between bottom wall 204′ andlingual wall 206′.

The mouth guards 200 and 200′ are sufficiently thick and rigid so thatno exoskeleton support is required when placing the mouth guard devicesover the teeth. For example, the mouth guards preferably have athickness between about 2 mm and about 5 mm, more preferably betweenabout 2 mm and about 4 mm, and most preferably between about 2 mm andabout 3 mm. Inclusion of one or more of the structural featuresdescribed advantageously allows the non-custom mouth guards to betterconform to the dental arch for which it is configured as compared to anon-custom mouth guard that does not include any such structuralfeatures. The non-custom mouth guards advantageously may be used withoutany required customization or fitting step as required with “boil andbite” mouth guards, while still providing a good fit to the dental arch.Alternatively, the mouth guards may be at least partially customized tothe dental arch through heating followed by subsequent conforming to thedental arch (i.e., boil and bite). In such an embodiment, the presenceof one or more of the described structural features enables the mouthguard to better conform to the teeth, particularly after customization,because the structural features provide a better fit to begin with,i.e., prior to any customization. Furthermore, because the structuralfeatures result in improved fit, less thickness is required to deliverany given level of protection and cushioning to the dental arch as themouth guard has better contact so as to cradle the hard and soft tissuesof the dental arch. Finally, the relatively thinner mouth guards aregenerally more comfortable to wear as compared to a thicker mouth guard.

FIG. 3 illustrates an example of a dental treatment tray 300 nestedwithin an exoskeleton 300 a, which provides support to tray 300. Tray300 includes a moisture-resistant barrier layer 301 having alabial-buccal wall 302, a bottom wall 304, and a lingual wall 306. Thetray 300 is held within and supported by exoskeleton 300 a, which ishelpful during placement of the tray over a dental arch. A substantiallysolid adhesive composition 314 is disposed adjacent to an inside surfaceof barrier layer 301 (e.g., adjacent to labial-buccal wall 302 and/orbottom wall 304). In one example, the adhesive composition 314 may be adry insert having the same shape as the tray that is placed within thetray 300.

FIG. 4 illustrates an example of another dental treatment tray 400nested within an exoskeleton 400 a. Tray 400 includes amoisture-resistant barrier layer 401 having a labial-buccal wall 402, abottom wall 404, and a lingual wall 406. The tray 400 is held within andsupported by exoskeleton 400 a, which is helpful during placement of thetray over a dental arch. A gel treatment composition 414 is disposedadjacent to an inside surface of barrier layer 401 (e.g., adjacent tolabial-buccal wall 402 and/or bottom wall 404). The treatmentcompositions (e.g., 314 and/or 414) may be pre-applied duringmanufacture and packaging of the dental treatment tray devices. Such aconfiguration advantageously eliminates any requirement for the user todispense a treatment composition into the tray prior to use.Alternatively, the treatment compositions may be dispensed by the userinto the tray just prior to use.

In some embodiments, more than one type of treatment and/or adhesivecomposition may be dispensed within the tray. For example, asubstantially solid adhesive composition may be disposed adjacent thelingual wall for adhering the tray to the lingual tooth surface and agel treatment composition may be disposed adjacent the labial-buccalwall, the bottom wall, and/or the lingual wall so as to contact thelabial-buccal tooth surface, and optionally one or both of the occlusaland lingual tooth surfaces during treatment. In another example, one ofthe compositions may be intended to contact the gums, but to provide notreatment. Such a composition preferably contains no dental bleachingagent which otherwise may irritate the soft tissue surrounding the teeth(e.g., gingival tissue). Such a composition may advantageously act toreduce or prevent contact between the treatment composition containing atreatment agent and the person's soft tissue.

In order to protect one or more of the non-custom dental tray devicesaccording to the invention from contaminants during storage and prior touse, the devices can be packaged within a sealed container or package.As illustrated in FIG. 5, the non-custom treatment tray 100, along withan associated exoskeleton 100 a (i.e., configured for placement over theupper dental arch) can be sealed within a protective package 516 thatincludes a rigid support layer 518 and a peelable cover 520. Asillustrated, package 516 may advantageously also include a non-customtreatment tray 100′ and associated exoskeleton 100 a′ configured forplacement over the lower dental arch, such that package 516 includestreatment tray devices for use over both the upper and lower dentalarches. When it is desired to use the dental treatment tray devices, thepeelable cover 520 is removed and the tray devices 100 and 100′, alongwith the included support exoskeletons are removed or separated fromsupport layer 518. In addition to, or instead of, the protective package516, the tray devices may alternatively include a removable protectivelayer (not shown) that is temporarily placed adjacent to the interiorsurface of the treatment compositions 114 and 114′. When it is desiredto use the tray device, the removable protective layer is removed so asto expose the interior surface of the adhesive composition and/or othertreatment composition. In addition, prior to using the tray device, agel or putty treatment composition may be applied to the inside of thedevice (e.g., as shown in FIG. 4).

In general, the thickness of any substantially solid adhesivecomposition layer and the barrier layer can be adjusted to yield atreatment tray device having a desired strength and flexibility. Inorder for the barrier layer to remain flexible so as to conform to aperson's teeth, the barrier layer will generally have a thicknessranging from about 0.025 mm to about 2 mm, more preferably between about0.05 mm and about 1 mm, and most preferably between about 0.1 and about0.5 mm. When present, a substantially solid adhesive composition willgenerally have a thickness ranging from about 0.1 mm to about 3 mm. Thethickness of the adhesive composition can also be selected depending onthe intended duration of each bleaching session. In general, increasingthe thickness of the adhesive composition layer where the adhesivecomposition includes a dental bleaching agent will provide a longer ormore sustained release of active dental bleaching agent. By way ofexample, for short wear times, the adhesive composition layer includinga dental bleaching agent will preferably have a thickness ranging fromabout 0.1 mm to about 0.5 mm. For intermediate wear times, the adhesivecomposition layer including a dental bleaching agent will preferablyhave a thickness ranging from about 0.5 mm to about 2 mm. Forprofessional use and for overnight bleaching, the adhesive compositionlayer having a dental bleaching agent will preferably have a thicknessranging from about 2 mm to about 3 mm.

III. EXEMPLARY METHODS OF MAKING NON-CUSTOM DENTAL TRAY DEVICES

According to one method of manufacturing an exemplary treatment traydevice, an adhesive composition is made by first forming a flowablecomposition that is later dried to form a substantially solid adhesivecomposition. This may be performed by heating or otherwise causing oneor more volatile solvents to be driven off by evaporation, thus leavingbehind a substantially solid composition. The drying process may beperformed before or after the adhesive composition is placed intocontact with the barrier layer.

According to one embodiment, dental treatment tray devices can be madeby spreading a flowable adhesive composition onto the surface of a largeor continuous polymeric sheet. The polymeric sheet and adhesivecomposition are then placed into a forced air oven, other appropriatedesiccation device, or allowed to dry in ambient conditions. Drying thesheet and adhesive composition drives off a substantial portion of theethanol or other solvent used to form the flowable adhesive composition.Removal of the volatile solvent yields a substantially solid adhesivecomposition. Thereafter, individual dental treatment tray devices can bemolded, such as by vacuum forming, pressing or stamping from the coatedpolymeric sheet and then separated into individual dental treatment traydevices suitable for placement over a person's teeth.

Alternatively, a flowable adhesive composition or a substantially solidadhesive composition can be molded or shaped into a desired tray-likeconfiguration. Thereafter, a barrier layer may be attached or applied toan outer surface of the adhesive composition layer. In this embodiment,the barrier layer may initially comprise a flowable barrier material orprecursor that is later cured or hardened, such as by removing a solventby evaporation, by chemical or light curing, or by cooling athermoplastic melt.

In yet another embodiment of the invention, a barrier layer having alabial-buccal wall, a lingual wall, and a bottom wall can be coated witha flowable adhesive composition. The adhesive composition is then heatedtogether with the barrier layer or otherwise allowed to dry in order toform a substantially solid adhesive composition. This process can beperformed during commercial manufacture of the dental treatment traydevices or by an end user.

Sticky viscous gels, less viscous gels, and/or highly viscous puttiesmay be manufactured separate from the barrier layer. They may be appliedto the barrier layer or an adhesive composition prior to packaging, ifdesired. Alternatively, the dental treatment tray devices can beprovided with a separate gel or putty which the end user may apply.

The dental treatment tray devices may be placed within an optionalexoskeleton during the manufacturing process prior to packaging, ifdesired. Alternatively, the tray-shaped dental treatment devices may beprovided with a separate exoskeleton, or without an exoskeleton, asdesired (e.g., a substantially solid adhesive composition may providesufficient strength, support, and rigidity to the barrier layer,eliminating the need for an exoskeleton).

In the case of the relatively thick mouth guards, individual mouth guarddevices can be molded (e.g., vacuum formed, pressed, or stamped) from alarge sheet of polymer material, after which the mouth guard devices maybe separated and packaged. Such a package may contain a mouth guardconfigured for use over the upper dental arch and a mouth guardconfigured for use over the lower dental arch).

IV. EXEMPLARY METHODS OF USING NON-CUSTOM DENTAL TREATMENT TRAY DEVICES

The dental tray devices according to the invention can be designed to beworn for any desired time period. In the case of a dental treatmenttray, increasing the concentration of dental bleaching agent in thetreatment composition(s) generally reduces the bleaching time requiredto effect bleaching. Nevertheless, due to the extremely comfortable fitbetween the inventive non-custom dental treatment trays and the person'steeth, it is possible to wear such devices for extended periods of timein order to ensure more uniform bleaching. Especially with respect todental treatment trays including a substantially solid adhesivecomposition layer, they may be designed to be worn while performingnormal daily activities, such as talking, eating, drinking, smoking,coughing, smiling, frowning, grimacing, or while sleeping. This greatlydecreases their intrusiveness into everyday activities compared toconventional bleaching strips, which do not reliably adhere to teeth, orintrusive bleaching devices such as large, bulky bleaching dentalappliances.

FIG. 6A illustrates a person 622 placing a dental treatment tray 600over the person's upper dental arch using an exoskeleton as a support.FIG. 6B illustrates the person 622 placing a dental treatment tray 600′over the person's lower dental arch after having placed the tray 600over the upper dental arch. It will be appreciated, however, that thedental treatment tray devices can be placed over a person's upper andlower dental arches in any desired order.

The dental treatment tray devices 600 and 600′ include a narrowing ofbottom wall 604 at locations 608 and 608′, respectively. FIGS. 7A and 7Billustrate how the narrowing of the bottom wall helps the bottom wallbetter conform to abrupt changes in the occlusal surface diameter, ofthe posterior teeth as compared to the anterior teeth. This abruptchange is most apparent at a location where the first bicuspid meets thecanine (i.e., locations 608 and 608′). FIG. 7A shows a view of the upperdental arch from an occlusal perspective, so as to better illustrate howthe occlusal surface of the molars and bicuspids is substantiallygreater in surface area, diameter, and width as compared to the occlusalsurface of the canines and incisors. An abrupt tuck or narrowing ofbottom wall 604 occurs between the first bicuspids 621 and canines 623on each side of the upper dental arch, which allows the bottom wall andtray device 600 to better conform to the topology and shape of theteeth.

FIG. 7B shows a view of the lower dental arch, also from an occlusalperspective, so as to better illustrate how the occlusal surface of themolars and bicuspids is substantially greater in surface area, diameter,and width relative to the occlusal surfaces of the canines and incisors.An abrupt tuck or narrowing of bottom wall 604′ occurs between firstbicuspids 621′ and canines 623′ on each side of the upper dental arch,which allows the bottom wall and tray device 600′ to better conform tothe topology and shape of the teeth of the dental arch. It will furtherbe noted that the teeth of the lower dental arch are substantiallysmaller than the teeth of the upper dental arch, particularly whencomparing corresponding bicuspids, canines, and incisors. As alreadydescribed, the overall dimensions of tray 600′ generally are somewhatsmaller than those of tray 600 to account for these differences.

FIG. 8A is a close up cross sectional view illustrating how thetransition portion 605 between bottom wall 604 and lingual wall 606 hasa radius of curvature R₁ that is larger than the radius of curvature R₂of the transition portion 603 between bottom wall 604 and labial-buccalwall 602. Radius of curvature R₁ is preferably between about 65 mm andabout 200 mm, more preferably between about 100 mm and about 160 mm, andmost preferably between about 115 mm and about 140 mm. Radius ofcurvature R₂ is preferably between about 15 mm and about 55 mm, morepreferably between about 20 mm and about 50 mm, and most preferablybetween about 30 mm and about 40 mm. The transition from occlusal tolingual tooth surfaces of the posterior teeth of the upper dental archis typically more gently curved than the transition from occlusal tolabial-buccal tooth surfaces of the posterior teeth of the upper dentalarch. Moreover, the teeth of the upper dental arch, particularly theupper posterior teeth, are generally angled or oriented in an outwarddirection (i.e., the longitudinal axis of each of the teeth of the upperdental arch is angled slightly in a labial-buccal direction from thevertical). For these reasons, providing a radius of curvature R₁ that isgreater than R₂ results in a better fit between the non-custom traydevice and the upper dental arch. In addition, lingual wall 606 includesan “S” type curve to advantageously provide a more comfortable fitagainst the lingual gum tissue 607.

FIG. 8B is a close up cross sectional view illustrating how thetransition portion 603′ between bottom wall 604′ and labial-buccal wall602′ has a radius of curvature R₂′ that is larger than the radius ofcurvature R₁′ of the transition portion 605′ between bottom wall 604′and lingual wall 606′. Radius of curvature R₁′ is preferably betweenabout 15 mm and about 45 mm, more preferably between about 20 mm andabout 40 mm, and most preferably between about 30 mm and about 35 mm.Radius of curvature R₂′ is preferably between about 30 mm and about 85mm, more preferably between about 40 mm and about 75 mm, and mostpreferably between about 50 mm and about 60 mm. The transition fromocclusal to labial-buccal tooth surfaces of the posterior teeth of thelower dental arch is typically more gently curved than the transitionfrom occlusal to lingual tooth surfaces of the posterior teeth of thelower dental arch. Moreover, the teeth of the lower dental arch,particularly the lower posterior teeth, are generally angled or orientedin an inward direction (i.e., the longitudinal axis of each of the teethof the lower dental arch is angled slightly in a lingual direction fromthe vertical). For these reasons, providing a radius of curvature R₂′that is greater than R₁′ results in a better fit between the non-customtray device and the lower dental arch.

Furthermore, each bottom wall 604 and 604′ includes a V-shapedindentation 612, 612′ for insertion into the depression between theocclusal peaks of the posterior teeth (i.e., the bicuspids and molars).As seen, upper second bicuspids 624 and 624 a and lower second bicuspids624′ and 624 a′ include depressions 626, 626 a, and 626′, 626 a′respectively, into which V-shaped indentations 612 and 612′ areconfigured to be inserted. This results in better conformity between thedental treatment trays 600 and 600′ and the posterior teeth (i.e.,bicuspids and molars), even when downward pressure is applied to bottomwalls 604 and 604′.

In the absence of such indentations, the bottom wall of the treatmentdevice may have a tendency to span the posterior teeth like a bridgebetween the generally higher outer edges, thereby leaving a gap betweenthe bottom walls 604 and 604′ and the surface of the posterior teethbetween the outer edges. Permitting such a gap may inhibit or preventbleaching of the depressed bicuspid and molar surfaces. Moreover, abottom wall that is stretched between the outer surfaces so as to leavea gap over the posterior teeth depressions may result in inadvertentdislodgment of the treatment tray devices when the upper and lowerbicuspids and/or molars are brought together. For example, if the bottomwall 604, 604′ of a treatment tray device is pushed into thebicuspid/molar depressions by the opposing bicuspids and/or molars, thelabial-buccal and/or bottom walls may be pulled down across the toothsurfaces to compensate for this effective lengthening of the bottom wall604, 604′ in the vicinity of the patient's posterior teeth.

To remove the dental treatment tray device, a user can pry open a cornerof the barrier layer using a fingernail or rigid tool and then pull theremainder off. Any residual adhesive composition or gel or puttytreatment composition that remains adhered to the person's teeth can beremoved by washing or flushing water over the person's teeth, and/or bybrushing. Although the adhesive compositions are very adhesive to teethwhen protected from excessive moisture, they can be formulated toquickly breakdown and dissolve when flushed with excess water and/or bygentle mechanical action (e.g., brushing).

The dental treatment tray devices can be worn for as little as a fewminutes and as long as several hours. By way of example, not limitation,a typical bleaching session of fast duration may last from about 10 toabout 30 minutes. A bleaching session of intermediate duration may lastfrom about 30 minutes to about 2 hours. A bleaching session of longduration, including professional bleaching or overnight bleaching whilea person is sleeping, may last from about 2 hours to about 12 hours.

Bleaching sessions may be repeated as many times as are needed to obtaina desired degree of whitening. In some cases, a clinical whiteningeffect has been observed after only 1-3 whitening sessions. A typicalbleaching regimen will preferably include 1-20 bleaching sessions, morepreferably 2-15 bleaching sessions, and most preferably 3-10 bleachingsessions.

V. EXEMPLARY KITS INCLUDING MULTIPLE DENTAL TRAY DEVICES

For convenience of use, multiple dental treatment tray devices may bepackaged together and sold as a kit. In one embodiment, the number ofpairs of treatment trays (i.e., one upper tray and one lower tray)provided with each kit will equal the number of sessions that representa prescribed bleaching regimen.

To efficiently use the space within a kit package, multiple dentaltreatment tray devices can be stacked or interested together. Thedevices can be sealed collectively or individually as desired. Aprotective package 516 is depicted in FIG. 5. The treatment tray devicesmay optionally contain a removable protective layer on an interiorsurface to protect the adhesive composition from contamination ormoisture.

It is within the scope of the invention to provide exoskeletons, barrierlayers, gel or putty treatment compositions, and/or adhesivecompositions that are initially separate and that are brought togetherby the end user. For example, the adhesive composition may be a dryinsert that is placed into the inventive tray-shaped barrier layer, withor without actually adhering the adhesive composition to the barrierlayer. Alternatively, a flowable adhesive composition can be placedwithin a tray-shaped barrier layer with structural features and allowedto dry prior to placement of the finished tray-shaped dental treatmentdevice over the person's teeth.

VI. EXAMPLES OF THE PREFERRED EMBODIMENTS

Following is an example of a dental bleaching composition and a dentaltreatment tray device that has been manufactured according to theinvention. Additional examples of treatment compositions and barrierlayer materials that may be used are disclosed in U.S. Pat. No.7,074,042, hereby incorporated by reference with respect to examples ofbarrier layer materials and treatment compositions. The exemplaryformulations and manufacturing conditions are given by way of example,and not by limitation, in order to further illustrate dental treatmenttray devices that have been found to be useful for bleaching a person'steeth. Unless otherwise indicated, all percentages are by weight.

EXAMPLE 1

An initially flowable adhesive composition suitable for use inmanufacturing a substantially solid adhesive composition was formed bymixing together the following components:

Ethanol 31.95%   Water 10% Polyvinyl Pyrrolidone (M.W. = 1.3 million)27% Polyvinyl Pyrrolidone (M.W. of about 60,000) 10% Sodium LaurelSulfate 0.5%  Glycerine 15% Sucralose 25% solution 0.5%  Peach Flavor 4% Potassium Nitrate 0.8%  Sodium Fluoride 0.25%  

The resulting adhesive composition was spread over the surface of alarge flat sheet formed of 80% ethyl vinyl acetate and 20%polypropylene. The EVA/PP sheet had a thickness of about 0.15 mm. Theadhesive composition was spread using a skreeding device. The coatedsheet was heated in a forced air oven until the adhesive compositiondried. The coated sheet was removed from the oven and inspected. Theadhesive composition had dried sufficiently so as to form asubstantially solid layer on the surface of the polymer sheet. Theadhesive composition was dry to the touch, but became very sticky whentouched by a wet object. After drying, the adhesive composition film wasreduced to approximately one-third of its original thickness when wet.

The coated sheet was thermoformed into dental treatment tray deviceswith the dry adhesive composition on the inside surface of the traydevices. Individual tray-shaped devices were cut out using dye cuttingtools. A laser could alternatively be used for cutting. The tray-shapeddevices included a labial-buccal wall, a lingual wall, and a bottom wallin which the width of the bottom wall was abruptly narrowed at alocation corresponding to where the first bicuspids meet the canines soas to help the bottom wall better conform to abrupt changes in thediameter and occlusal surface width of a person's teeth, particularlywhere the bicuspids and canines meet. The tray-shaped devices configuredfor placement over the upper dental arch further included a transitionportion between the bottom wall and the lingual wall having a largerradius of curvature as compared to a radius of curvature at a transitionportion between the bottom wall and the labial-buccal wall. Thetray-shaped devices configured for placement over the lower dental archfurther included a transition portion between the bottom wall and thelabial-buccal wall having a larger radius of curvature as compared to aradius of curvature at a transition portion between the bottom wall andthe lingual wall.

A bleaching gel treatment composition for use with the dental treatmenttray devices was prepared by mixing together the following components:

Water 22.5% EDTA Disodium  0.1% Carbamide Peroxide 18.5% Sucralose 25%solution 0.75% Glycerine 41.6% Carbopol 974  5.3% Sodium Hydroxide 50%solution 2.25% Polyvinyl Pyrrolidone (M.W. = 1.3 million)   2%Carboxymethyl Cellulose   4% Watermelon Flavor   3%

The dental treatment tray devices were placed in a holding device, and abead of bleaching gel treatment composition was spread along thelabial-buccal wall of the bleaching tray devices. Each tray-shapeddevice was then transferred to an exoskeleton.

The dental treatment tray devices were tested by placing them over aperson's teeth. The residual saliva present on the tooth surfacesmoistened the exposed surface of the adhesive composition and caused itto become sticky and very adhesive to teeth almost immediately. Thenon-custom dental treatment tray devices were pressed against the teeth,which caused them to conform to the natural irregularities of the dentalarch and adhere firmly against the teeth.

In the tray configured for placement over the upper dental arch, thebottom wall had it greatest width of about 10 mm across the portionadapted to receive the bicuspids and/or molars. At a locationcorresponding to a transition from the first bicuspids to the canines,the bottom wall narrowed to a width of about 1.5 mm. The narrowing ofthe bottom wall on both the right and left sides corresponding to alocation where the first bicuspid meets the canine helped the bottomwall better conform to abrupt changes in the occlusal surface width of aperson's teeth, particularly where the bicuspids and canines meet. Thetransition portion between the bottom wall and the lingual wall had aradius of curvature of about 130 mm, while the transition portionbetween the bottom wall and the labial-buccal wall had a radius ofcurvature of about 35 mm. This difference in curvature of the transitionportions between the bottom wall and the other walls resulted in a goodfit between the non-custom tray device and the upper dental arch.

In the tray configured for placement over the lower dental arch, thebottom wall had it greatest width of about 9 mm across the portionadapted to receive the bicuspids and/or molars. At a locationcorresponding to a transition from the first bicuspids to the canines,the bottom wall narrowed to a width of about 2.5 mm. The narrowing ofthe bottom wall on both the right and left sides corresponding to alocation where the first bicuspid meets the canine helped the bottomwall better conform to abrupt changes in the occlusal surface width of aperson's teeth, particularly where the bicuspids and canines meet. Thetransition portion between the bottom wall and the lingual wall had aradius of curvature of about 32 mm, while the transition portion betweenthe bottom wall and the labial-buccal wall had a radius of curvature ofabout 57 mm. This difference in curvature of the transition portionsbetween the bottom wall and the other walls resulted in a good fitbetween the non-custom tray device and the lower dental arch.

The dental treatment tray devices were worn for varying time periodsranging from several minutes to several hours without becomingdislodged. In some cases a noticeable bleaching effect was detectedafter just one bleaching session (e.g., a 2-hour bleaching session). Inall cases, noticeable bleaching was detected after 1-3 bleachingsessions.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A pre-shaped, non-customized dental tray device suitable forplacement over at least a portion of a person's dental arch, the dentaltray device comprising: a generally horseshoe-shaped moisture resistantbarrier layer configured to substantially correspond to the curvature ofa person's dental arch, the barrier layer having a labial-buccal wall, alingual wall, and a bottom wall interposed between the labial-buccalwall and the lingual wall, the barrier layer having an anterior regionthat at least partially covers anterior tooth surfaces when worn and aposterior region that at least partially covers posterior tooth surfaceswhen worn, the barrier layer being substantially devoid of structurescorresponding to the size and shape of a person's unique dentition sothat the barrier layer is designed to comfortably fit over a pluralityof differently-sized and/or shaped teeth corresponding to differentpeople; the moisture resistant barrier layer comprising one or morestructural features that facilitate the ability of the barrier layer toconform to a plurality of differently-sized and/or shaped teeth whenworn, the one or more structural features being selected from the groupconsisting of: (a) an abrupt reduction in width of the bottom wall at alocation corresponding to a transition between the posterior region andthe anterior region of the barrier layer to account for a significantdifference between the occlusal surface width of posterior teeth ascompared to anterior teeth; and (b) a width of the bottom wall in theposterior region being equal to or less than a width of the bottom wallin the anterior region, the lingual wall terminating at or before thetransition between the posterior and anterior regions.
 2. A pre-shaped,non-customized dental tray device as defined in claim 1, wherein thewidth of the bottom wall is abruptly reduced at a location correspondingto a transition between a first bicuspid and a canine.
 3. A pre-shaped,non-customized dental tray device as defined in claim 2, wherein thedental tray device is configured for placement over a person's upperdental arch, and the width of the bottom wall is reduced between about60 percent and about 95 percent at a location corresponding to atransition between a first bicuspid and a canine.
 4. A pre-shaped,non-customized dental tray device as defined in claim 2, wherein thedental tray device is configured for placement over a person's upperdental arch, and the width of the bottom wall is reduced between about75 percent and about 90 percent at a location corresponding to atransition between a first bicuspid and a canine.
 5. A pre-shaped,non-customized dental tray device as defined in claim 2, wherein thedental tray device is configured for placement over a person's lowerdental arch, and the width of the bottom wall is reduced between about40 percent and about 90 percent at a location corresponding to atransition between a first bicuspid and a canine.
 6. A pre-shaped,non-customized dental tray device as defined in claim 2, wherein thedental tray device is configured for placement over a person's lowerdental arch, and the width of the bottom wall is reduced between about50 percent and about 85 percent at a location corresponding to atransition between a first bicuspid and a canine.
 7. A pre-shaped,non-customized dental tray device as defined in claim 2, wherein thedental tray device is configured for placement over a person's lowerdental arch, and the width of the bottom wall is reduced between about60 percent and about 80 percent at a location corresponding to atransition between a first bicuspid and a canine.
 8. A pre-shaped,non-customized dental tray device as defined in claim 1, wherein thedental tray device is configured for placement over a person's lowerdental arch, wherein a transition portion between the bottom wall andthe labial-buccal wall of the barrier layer has a radius of curvaturethat is larger than a radius of curvature at a transition portionbetween the bottom wall and the lingual wall.
 9. A pre-shaped,non-customized dental tray device as defined in claim 8, wherein theradius of curvature of the transition portion between the bottom walland the labial-buccal wall is between about 30 mm and about 85 mm, andthe radius of curvature of the transition portion between the bottomwall and the lingual wall is between about 15 mm and about 45 mm.
 10. Apre-shaped, non-customized dental tray device as defined in claim 8,wherein the width of the bottom wall is abruptly reduced at a locationcorresponding to a transition between a first bicuspid and a canine. 11.A pre-shaped, non-customized dental tray device as defined in claim 1,wherein the dental tray device is configured for placement over aperson's upper dental arch, wherein a transition portion between thebottom wall and the lingual wall of the barrier layer has a radius ofcurvature that is larger than a radius of curvature at a transitionportion between the bottom wall and the labial-buccal wall.
 12. Apre-shaped, non-customized dental tray device as defined in claim 11,wherein the radius of curvature of the transition portion between thebottom wall and the lingual wall is between about 65 mm and about 200mm, and the radius of curvature of the transition portion between thebottom wall and the labial-buccal wall is between about 15 mm and about55 mm.
 13. A pre-shaped, non-customized dental tray device as defined inclaim 11, wherein the width of the bottom wall is abruptly reduced at alocation corresponding to a transition between a first bicuspid and acanine.
 14. A pre-shaped, non-customized dental tray device as definedin claim 1, wherein the dental tray device comprises a dental treatmenttray, the barrier layer being flexible and having a thickness less thanabout 2 mm so as to readily conform to a plurality of differently-sizeddental arches corresponding to different people.
 15. A pre-shaped,non-customized dental tray device as defined in claim 14, wherein thebarrier layer has a thickness less than about 1 mm.
 16. A pre-shaped,non-customized dental tray device as defined in claim 14, wherein thebarrier layer has a thickness less than about 0.5 mm.
 17. A pre-shaped,non-customized dental tray device as defined in claim 1, wherein thedental tray device comprises a mouth guard and the barrier layer has athickness greater than about 2 mm.
 18. A pre-shaped, non-customizeddental tray device as defined in claim 1, wherein the bottom wallfurther includes a notch positioned so that the dental tray device moreeasily spreads open or compresses in a region near a person's incisors.19. A pre-shaped, non-customized dental tray device as defined in claim1, wherein a posterior portion of the lingual wall further comprises an“S” type curve such that an extreme upper posterior portion of thelingual wall is flared in a lingual direction so as to fit morecomfortably against lingual gum tissue.
 20. A pre-shaped, non-customizeddental tray device as defined in claim 1, wherein the dental tray devicecomprises a dental treatment tray, further comprising a dental treatmentcomposition disposed adjacent to the barrier layer.
 21. A pre-shaped,non-customized dental tray device as defined in claim 1, wherein thewidth of the bottom wall is abruptly reduced at a location correspondingto a transition between posterior teeth and anterior teeth, and whereinthe lingual wall terminates at or before the transition between theposterior and anterior regions such that the lingual wall extendsadjacent to only the anterior teeth during use.
 22. A pre-shaped,non-customized dental tray device as defined in claim 1, wherein thewidth of the bottom wall in the posterior region is equal to or lessthan a width of the bottom wall in the anterior region, and wherein thelingual wall terminates at or before the transition between theposterior and anterior regions such that the lingual wall extendsadjacent to only the anterior teeth during use.
 23. A pre-shaped,non-customized dental tray device as defined in claim 22, wherein thedental tray device is configured for placement over the upper dentalarch and wherein the width of the bottom wall in the anterior region isbetween about 1 and about 3 mm.
 24. A pre-shaped, non-customized dentaltray device as defined in claim 22, wherein the dental tray device isconfigured for placement over the lower dental arch and wherein thewidth of the bottom wall in the anterior region is between about 1 andabout 4
 25. A pre-shaped, non-customized dental tray device as definedin claim 1, farther comprising a support skeleton positionable adjacentto the barrier layer prior to placement over the person's teeth so as tohelp maintain the barrier layer in a tray-like configuration andfacilitate placement of the barrier layer over the person's teeth.
 26. Apre-shaped, non-customized dental tray device suitable for placementover at least a portion of a person's dental arch, the dental traydevice comprising: a generally horseshoe-shaped moisture resistantbarrier layer configured to substantially correspond to the curvature ofa person's dental arch, the barrier layer having an anterior region thatat least partially covers anterior teeth surfaces when worn and aposterior region that at least partially covers posterior teeth surfaceswhen worn, the barrier layer having a labial-buccal wall in theposterior and anterior regions, a lingual wall in the anterior regionbut not the posterior region, and a bottom wall interposed between thelabial-buccal wall and the lingual wall in the anterior region andextending laterally relative to the labial-buccal wall in the posteriorregion, the barrier layer being substantially devoid of stricturescorresponding to the size and shape of a person's unique dentition sothat the barrier layer is designed to comfortably fit over a pluralityof differently-sized and/or shaped teeth corresponding to differentpeople.
 27. A pre-shaped, non-customized dental tray device as definedin claim 26, there being an abrupt reduction in width of the bottom wallat a location corresponding to a transition between the posterior regionand the anterior region of the barrier layer to account for asignificant difference between the occlusal surface width of posteriorteeth as compared to anterior teeth.
 28. A pre-shaped, non-customizeddental tray device as defined in claim 26, a width of the bottom wall inthe posterior region being equal to or less than a width of the bottomwall in the anterior region, the lingual wall terminating at or beforethe transition between the anterior and posterior regions.
 29. Apre-shaped, non-customized dental tray device as defined in claim 28,wherein the dental tray device is configured for placement over theupper dental arch and wherein the width of the bottom wall in theanterior region is about 1.5 mm.
 30. A pre-shaped, non-customized dentaltray device as defined in claim 28, wherein the dental tray device isconfigured for placement over the lower dental arch and wherein thewidth of the bottom wall in the anterior region is about 2.5 mm.
 31. Adental tray device kit, comprising: a first dental tray deviceconfigured for placement over at least a portion of a person's lowerdental arch comprising: a generally horseshoe-shaped moisture resistantbarrier layer configured to substantially correspond to the curvature ofa person's dental arch, the barrier layer having a labial-buccal wall, alingual wall, and a bottom wall interposed between the labial-buccalwall and the lingual wall, the barrier layer being substantially devoidof structures corresponding to the size and shape of a person's uniquedentition so that the barrier layer is designed to comfortably fit overa plurality of differently-sized and/or shaped teeth corresponding todifferent people such that the barrier layer is adapted to be worn overat least a portion of a person's lower dental arch without customizationprior to wearing; a bottom wall to labial-buccal wall transitionportion, the transition portion having a radius of curvature that islarger than a radius of curvature at a transition portion between thebottom wall and the lingual wall; and a second dental tray deviceconfigured for placement over at least a portion of a person's upperdental arch comprising: a generally horseshoe-shaped moisture resistantbarrier layer configured to substantially correspond to the curvature ofa person's dental arch, the barrier layer having a labial-buccal wall, alingual wall, and a bottom wall interposed between the labial-buccalwall and the lingual wall, the barrier layer being substantially devoidof structures corresponding to the size and shape of a person's uniquedentition so that the barrier layer is designed to comfortably fit overa plurality of differently-sized and/or shaped teeth corresponding todifferent people such that the barrier layer is adapted to be worn overat least a portion of a person's upper dental arch without customizationprior to wearing; a bottom wall to lingual wall transition portion, thetransition portion having a radius of curvature that is larger than aradius of curvature at a transition portion between the bottom wall andthe labial-buccal wall.
 32. A kit as defined in claim 31, wherein thebottom wall of the first dental tray and/or the second dental trayfurther comprises an abrupt reduction in a width of the bottom wall at alocation corresponding to a transition portion between posterior teethand anterior teeth to account for a significant difference between theocclusal surface width of posterior teeth as compared to anterior teeth.33. A pre-shaped, non-customized dental tray device as defined in claim31, a width of the bottom wall in the posterior region being equal to orless than a width of the bottom wall in the anterior region, the lingualwall terminating at or before the transition between the anterior andposterior regions.